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The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Duchesnay Inc.
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00405288
First received: November 28, 2006
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.


Condition Intervention Phase
Hemorrhoids
Pregnancy
Drug: Proctofoam-HC®
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Birth-weight [ Time Frame: until delivery ] [ Designated as safety issue: Yes ]
    Weight of the baby measured in grams at time of birth.


Secondary Outcome Measures:
  • Gestational Age at Delivery [ Time Frame: until delivery ] [ Designated as safety issue: Yes ]
    Fetal gestational age at delivery

  • Mode of Delivery [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Method of delivery for both groups: vaginal or caesarean section

  • Prematurity [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    birth at <37 gestational weeks

  • Fetal Distress [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid

  • Low Birth Weight at Birth [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Low birth weight (birth weights <2500 grams)

  • Neonatal Health [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth


Enrollment: 408
Study Start Date: November 2006
Study Completion Date: June 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Proctofoam-HC®
Women in the third trimester of pregnancy prescribed Proctofoam-HC® aerosol foam canister for 36 applications for treatment of symptoms of hemorrhoids. One applicatorful is to be applied into the anus (or on the perianal area) two or three times daily and after bowel evacuation.
Drug: Proctofoam-HC®
Observational study of the exposure to Proctofoam-HC®
Other Name: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)
Control
Control group of women in the third trimester of pregnancy who were not exposed to any teratogens during the course of the pregnancy, and to Proctofoam-HC any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.

Detailed Description:

Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women.

Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain.

We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant woman with a primary anorectal condition during the third trimester of pregnancy and pregnant women in the third trimester of pregnancy without anorectal condition

Criteria

Inclusion Criteria:

  • For intervention group, any pregnant woman with a primary anorectal condition during the third trimester of pregnancy
  • For control group, women in third trimester of pregnancy not treated with Proctofoam, and matched on maternal age and smoking status
  • for either group,no other pregnancy complications

Exclusion Criteria:

  • exposure to known teratogens during pregnancy as evident either during the prenatal or postnatal interview
  • insufficient English language skills to understand the questionnaires and assessment material
  • Women who have received other corticosteroid medications (systemic or topical)during pregnancy
  • Women with the following conditions: abscess, fistula, tuberculosis, varicella, acute Herpes Simplex or fungal infection
  • age less than 18 years
  • History of previous reaction to any of the product's components, such as: local irritation, hypertrichosis, hypopigmentation, etc.
  • Known Intrauterine Growth Restriction (IUGR) or a chronic state that may cause IUGR (SLE, placental insufficiency).
  • Multi fetal pregnancy
  • Binge alcohol consumption (5 or more drinks on one occasion,in a row or within a short period of time)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405288

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Duchesnay Inc.
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Gideon Koren, Chief, Global Child Health, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00405288     History of Changes
Other Study ID Numbers: 1000008482
Study First Received: November 28, 2006
Results First Received: August 16, 2013
Last Updated: January 3, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Hemorrhoids
Pregnancy
antihemorrhoidal
Proctofoam
infants

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Pramoxine
Anesthetics
Anesthetics, Local
Anti-Inflammatory Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014